Regulatory Affairs Specialist

3 weeks ago


Bloemfontein, Orange Free State, South Africa Parexel Full time

About the Role:

We are seeking a highly skilled Senior Regulatory Affairs Associate to join our team at Parexel. As a key member of our regulatory team, you will be responsible for ensuring the timely performance of work within a project scope to the quality expectations of internal stakeholders and clients.

Key Responsibilities:

  • Manage local submissions as Local Regulatory Contact (LRC)
  • Coordinate regulatory submissions in all participating countries as Regulatory Lead
  • Regulatory submission of Clinical Trials in the region
  • Participate in Regulatory Operations meetings, project team meetings, and maintain relationships with other departments, clients, and regulatory agencies as necessary
  • Lead or be involved in local, regional, and/or global projects
  • Guide and mentor junior team members

Requirements:

  • University degree in a science discipline
  • Background in clinical trial management
  • 3-5 years of Regulatory Affairs experience working with Clinical Trial Applications in South Africa
  • Experience with clinical trial submissions in other Southern African Countries
  • IT knowledge (Veeva Regulatory and Clinical Vaults - Excel - VBA - Power BI)
  • Customer-oriented and autonomous
  • Fluency in English is a must along with the local language

About Parexel:

Parexel is a leading global biopharmaceutical services company that provides a comprehensive range of solutions to help clients accelerate the development and delivery of new and innovative treatments.



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